Mitralign said today that it won CE Mark approval in the European Union for its namesake device for treating functional mitral regurgitation.
Tewksbury, Mass.-based Mitralign said the approval covers patients with symptomatic FMR. Its device, delivered via catheter, is designed to use anchors to help restore the heart’s mitral valve to its natural shape. The company said the CE Mark was based on a single-arm study that met a 30-day safety endpoint and a 6-month performance endpoint.
“The CE Mark for FMR is the first approved indication for the Mitralign platform and it provides clear validation of the technology,” CEO Rick Geoffrion said in prepared remarks. “This key accomplishment lends momentum to our efforts with physicians and regulatory agencies to continue to study our platform, including the Trialign system for tricuspid repair.”
“The data show treatment with the Mitralign System is safe in FMR patients,” added Dr. Georg Nickenig of the University of Bonn. “Due to its versatility and small footprint, the device can be considered a front-line treatment option for patients with mitral regurgitation.”
Mitralign is also running the Scout feasibility trial of its Trialign tricuspid valve repair device, under an investigational device exemption from the FDA.